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January 2017 Blog Posts (22)

Water System Validation in Pharmaceuticals Industry 2017

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of…

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Added by John Robinson on January 31, 2017 at 5:09am — No Comments

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant,…

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Added by John Robinson on January 25, 2017 at 4:58am — No Comments

Recommended Practices for Anti-Retaliation Programs

WASHINGTON - The Occupational Safety and Health Administration today issued Recommended Practices for Anti-Retaliation Programs to help employers create workplaces in which workers feel comfortable voicing their concerns without fear of retaliation. The recommendations are intended to apply to all…

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Added by Henry Wilter on January 24, 2017 at 6:34pm — No Comments

Management for Medical Device Industry

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global…

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Added by John Robinson on January 23, 2017 at 7:46am — No Comments

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical,…

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Added by John Robinson on January 20, 2017 at 5:50am — No Comments

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…

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Added by Adam Fleming on January 20, 2017 at 5:19am — No Comments

Sweating Slab Syndrome Safety Hazards

Sweating Slab Syndrome presents many dangers in industrial facilities and other buildings that have concrete floors. 

Sweating Slab Syndrome is characterized by the regular formation of condensation on a concrete floor. Not only can this lead to slips and falls, but can also lead to mold growth and many other dangers.

Go Fan Yourself has created an infographic that highlights the dangers of Sweating Slab Syndrome and provides some tips for alleviating Sweating Slab…

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Added by Nikki Heinkel on January 19, 2017 at 12:18pm — No Comments

Working at height is one of the UK's leading causes of workplace fatalities & injuries. These pointers will reduce risks & make working at height safer.

Working at height is the leading cause of workplace fatalities & injuries in the UK. In 2013/14, the Health and Safety Executive published statistics which showed that working at height was responsible for more workplace fatalities than any other professional activity. It also revealed that working at height was the…

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Added by Alex on January 19, 2017 at 12:04pm — No Comments

Alternatives to AQL sampling plans do exist

Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.

So, what is AQL?

What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…

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Added by Adam Fleming on January 19, 2017 at 5:06am — No Comments

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…

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Added by Adam Fleming on January 18, 2017 at 5:02am — No Comments

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and…

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Added by Adam Fleming on January 17, 2017 at 6:56am — No Comments

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the…

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Added by John Robinson on January 16, 2017 at 5:46am — No Comments

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…

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Added by John Robinson on January 13, 2017 at 5:17am — No Comments

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines…

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Added by John Robinson on January 13, 2017 at 4:30am — No Comments

Regulatory Filing Requirements for medical devices in Japan

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

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Added by John Robinson on January 12, 2017 at 4:51am — No Comments

Work tools: key stats and areas of concern

Although we all know intuitively that power tools can be exceptionally dangerous if used without due care and attention, it remains far too easy to fall into the trap of thinking that the ones we’re most accustomed to are somehow made safer by dint of our familiarity with them.

 

However, numerous eye-opening statistics have been gathered in recent years to…

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Added by Alex on January 11, 2017 at 11:04am — No Comments

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of…

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Added by John Robinson on January 11, 2017 at 5:01am — No Comments

HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself…

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Added by John Robinson on January 10, 2017 at 4:41am — No Comments

Emerging Issues in Food Safety-Globally

The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food…

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Added by John Robinson on January 9, 2017 at 6:42am — No Comments

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure…

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Added by John Robinson on January 9, 2017 at 6:00am — No Comments

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swethakumar posted a blog post

Nebosh Course in Bangalore – Green World Group

Many people wish to serve society and they will be also expected to get an opportunity to work in the Safety Management field as their passion. In this case, NEBOSH courses help them to go beyond their dream.NEBOSH is an accredited international course in Occupational Health and Safety Management throughout the world and it is the UK based independent examining board. After successfully completed this…See More
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3 Hour Excel Automation Boot Camp: Pivot Tables, Top 10 Functions & Formulas, Basics of Macros and VBA at 26468 E Walker Dr, Aurora, Colorado 80016

September 17, 2019 from 1pm to 4pm
OVERVIEWPivotTables can help you sort and sift through large data sets to focus quickly on just the data elements that matter most to your specific needs. In addition, you’ll get tips on the easiest way to group your data. Most importantly, when you use the power of Microsoft Excel PivotTables, you’ll be saving time and making your job easier.WHY SHOULD YOU ATTENDAs an…See More
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Morgan Franklin posted a blog post

Benefits of First Aid Training in the Workplace

It is the legal duty of employers to have adequate first aid procedures in place. As stated by the UK Government Health and Safety Executive (HSE), this includes an obligation to assess risks and to take appropriate action to control the risks, and to also provide suitable facilities and safety equipment. As well as having a fully stocked first aid kit, businesses also need to have appointed first aiders who are trained in helping…See More
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HrishikeshRam posted blog posts
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Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

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